Cold Versus Hot Snare Endoscopic Mucosal Resection for Intermediate-Size Flat Nonpedunculated Colorectal Polyps: A Multicenter, Prospective, Randomized, Non-Inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 968
- 主要终点
- complete resection rate
研究概览
简要总结
This multicenter, prospective, randomized, non-inferiority trial aimed to compare the efficacy and safety of cold snare endoscopic mucosal resection (CS-EMR) and hot snare endoscopic mucosal resection (HS-EMR) for resection of intermediate-size (10-20 mm) flat nonpedunculated colorectal polyps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-75 years, irrespective of gender;
- •Flat sessile colorectal polyps confirmed by colonoscopy, classified as Paris classification 0-Is or 0-IIa, with a measured diameter ranging from 10 to 20 mm;
- •Subjects voluntarily agree to receive endoscopic treatment and sign written informed consent.
排除标准
- •Colonoscopic findings suggestive of submucosal invasion or malignant transformation of colorectal polyps;
- •Previous history of colorectal surgery;
- •Previous history of inflammatory bowel disease, familial adenomatous polyposis, or colorectal cancer;
- •Failure to discontinue anticoagulant and antiplatelet medications for a minimum of 1 week prior to the procedure;
- •Known coagulation disorders or bleeding diathesis;
- •Pregnant or breastfeeding women;
- •Patients complicated with malignant tumors, severe cardiovascular and cerebrovascular diseases, liver cirrhosis, chronic kidney disease, or other severe comorbidities that preclude tolerance to endoscopic resection.
研究组 & 干预措施
Cold snare endoscopic mucosal resection (CS-EMR)
Eligible colorectal polyps measuring 10-20 mm will be resected using CS-EMR.
干预措施: Cold snare endoscopic mucosal resection (CS-EMR) (Procedure)
Hot snare endoscopic mucosal resection (HS-EMR)
Eligible colorectal polyps measuring 10-20 mm will be resected using HS-EMR.
干预措施: Hot snare endoscopic mucosal resection (HS-EMR) (Procedure)
结局指标
主要结局
complete resection rate
时间窗: Within 14 days
All five biopsy specimens harvested from the resection margins after EMR resection yielded negative pathological findings. These five biopsy samples consisted of four specimens collected from the four quadrants of the resection wound margin and one specimen obtained from the wound base.
次要结局
- en bloc resection rate(Within one days)
- Unresectable rate of CS-EMR(Within one day)
- Intraprocedural bleeding(Within one day)
- Intraprocedural perforation(Within one day)
- Procedural time(Within one day)
- Delayed bleeding(Within 14 days)
- Delayed perforation(Within 14 days)
- Number of clips used(Within one day)